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United States · US · US:63020-230_16e9f7cd-6a19-4ad1-9431-8205898a33f1
NINLARO
Orange BookUNIISPLATC L01XG03
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeL01XG03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1163020230011 CAPSULE in 1 BLISTER PACK (63020-230-01)
- ndc1163020230021 BLISTER PACK in 1 CARTON (63020-230-02) / 3 CAPSULE in 1 BLISTER PACK (63020-230-03)
Annotations
UNII (FDA Substance ID)
46CWK97Z3K
IXAZOMIB CITRATE
RxCUI 1723734
Orange Book
N208462
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "46CWK97Z3K",
"rxcui": "1723734",
"inchikey": "MBOMYENWWXQSNW-AWEZNQCLSA-N",
"display_name": "IXAZOMIB CITRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"038f2461-834b-4488-9ebd-863c83eef5a7": {
"match": "brand_token",
"title": "NINLARO (IXAZOMIB) CAPSULE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
"spl_version": "16",
"published_date": "2025-08-20"
}
},
"productid": "63020-230_16e9f7cd-6a19-4ad1-9431-8205898a33f1",
"productndc": "63020-230",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "208462",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 2.3MG BASE",
"product_no": "001",
"approval_date": "Nov 20, 2015"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 3MG BASE",
"product_no": "002",
"approval_date": "Nov 20, 2015"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 4MG BASE",
"product_no": "003",
"approval_date": "Nov 20, 2015"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "IXAZOMIB CITRATE",
"proprietary_name": "NINLARO",
"active_ingred_unit": "mg/1",
"application_number": "NDA208462",
"marketing_category": "NDA",
"nonproprietary_name": "ixazomib",
"start_marketing_date": "20151120",
"active_numerator_strength": "2.3"
}Related drugs
Other records sharing ATC code L01XG03.
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